FDA Approval and Usage
On February 7‚ 2022‚ the FDA approved FLEQSUVY (baclofen oral suspension) by Azurity Pharmaceuticals for treating spasticity from multiple sclerosis and spinal cord diseases. It is a liquid formulation with 25 mg per 5 mL strength. Shake well before use to ensure proper dosage.
Indications and Limitations of Use
FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis‚ particularly for the relief of flexor spasms‚ concomitant pain‚ clonus‚ and muscular rigidity. It may offer some value in patients with spinal cord injuries and other spinal cord diseases. The suspension contains 25 mg per 5 mL (5 mg/mL)‚ and it should be administrated with caution and adherence to the prescribed dosage regimen to manage potential side effects effectively.
Side Effects and Dosage
Common side effects of FLEQSUVY may include drowsiness‚ dizziness‚ weakness‚ tiredness‚ headache‚ trouble sleeping‚ nausea‚ increased urination‚ or constipation. Serious side effects may include severe drowsiness‚ breathing problems‚ confusion‚ hallucinations‚ muscle weakness‚ itching‚ tingling‚ or twitching in hands‚ arms‚ feet‚ or legs‚ and fever.
For the oral dosage form in granules‚ the recommended initial dose for adults and children 12 years and older is 5 milligrams three times a day for three days‚ with a gradual dosage increase as needed and tolerated. The maximum daily dose should not exceed 80 milligrams (20 mg four times a day).
Legal Issues and Compliance
Regarding Fleqsuvy‚ the FDA granted approval for its use in treating spasticity resulting from multiple sclerosis and other spinal cord conditions. The medication‚ a baclofen oral suspension‚ is subject to specific guidelines to ensure legal compliance and patient safety. It is essential for healthcare providers and patients to adhere to the prescribed dosage and regulatory requirements to mitigate risks and maintain legal standards.
Generic Version and Regulatory Concerns
The FDA has approved a generic version of Fleqsuvy‚ providing a cost-effective alternative. However‚ caution is advised due to the risk of fraudulent online pharmacies selling illegal versions. It is crucial for patients to ensure authenticity and safety when obtaining generic medication. Regulatory compliance is essential to safeguard patients from potential harm and ensure adherence to legal standards.
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